MINNEAPOLIS - (Mealey's) Guidant LLC's proposed plea agreement to pay a criminal fine of $254,962 and criminal forfeiture of $42,079,675 for charges that it twice violated the Food, Drug and Cosmetic Act (FDCA) by submitting false or no information about changes made to its Prizm and Renewal...

Consumers can sue a drug company for selling a drug that was not manufactured pursuant to good manufacturing practices (GMP) and was, thus, "adulterated" under the Food, Drug and Cosmetic Act (FDCA). Such claims are not preempted by federal law, said the Eighth Circuit Court of Appeals. ( Allen...

PHILADELPHIA -- (Mealey's) The McNeil-PPC Inc. division of Johnson & Johnson on March 10 entered into a consent decree of permanent injunction with the federal government for manufacturing violations at three plants that resulted in several over-the-counter products being recalled and one plant...

SAN FRANCISCO -- The Scios Inc. subsidiary of Johnson & Johnson has agreed to plead guilty to a misdemeanor charge related to the off-label marketing of its Natrecor heart drug, to pay an $85 million fine and to serve three years' organizational probation, according to a brief filed Sept. 14...

SAN FRANCISCO - (Mealey's) In a 2-1 ruling, a panel of the Ninth Circuit U.S. Court of Appeals said April 16 that claims that a Medtronic drug pump and spine catheter caused a plaintiff to become a paraplegic are preempted explicitly and implicitly by federal medical device law and by U.S. Supreme...

ABINGDON, Va. - Abbott
Laboratories Inc. on May 7 pleaded guilty to one misdemeanor criminal charge
and agreed to pay $1.5 billion in criminal fines, civil penalties and
forfeiture for off-label marketing its anti-epilepsy drug Depakote despite
knowing that it was not effective for those purposes...

SAN FRANCISCO- (Mealey's) The Ninth Circuit U.S. Court of Appeals, sitting en banc , ruled Jan. 10 that federal law does not preempt, expressly or by implication, a state law failure-to-warn claim alleging that Medtronic Inc. violated its federal duty to report problems with a drug pump ( Richard...

CINCINNATI - (Mealey's) A plaintiff's claim that PLIVA Inc. failed to add a 2004 warning from the Reglan label to its label for generic metoclopramide is not preempted, a panel of the Sixth Circuit U.S. Court of Appeals said March 13 in what it described as question of first impression in the...